Comparison of the effect of three drugs injected in the knee joint for age-related knee degeneration

Not yet recruiting

Conditions: Unilateral primary osteoarthritisof knee,

Registration Number: CTRI/2020/03/024397

Lead Sponsor: ICMR

Brief Summary: *Background:* Knee osteoarthritis (OA) has become an important and disabling issue worldwide as the life expectancy has increased due to availability of better medical facilities, with a rise in the proportion of elderly population. Intra-articular injections provide a good treatment option for pain relief and disability limitation for a sizable number of patients who are not getting benefit from medicines and physiotherapy, but who are not willing for surgical management or who are not fit for surgery.

*Novelty: Ketorolac has been described as a new, cost-effective and safe option for intra-articular injections for knee OA, but there has not been any comparative study of intra-articular ketorolac with the well-described and used option â€“ intra-articular steroid.*

*Objectives:* Is the pain relief (as scored by VAS score) at 2 weeks, 6 weeks, 3 months and 6 months; functional outcome provided at 6 months and patient satisfaction at 6 months (assessed on a 5-point Likert scale) better with ketorolac injection than that provided with steroid injection for symptomatic knee osteoarthritis?

*Methods: In this randomized controlled double-blinded study, intra-articular injections will be given for symptomatic knee osteoarthritis patients. 30 patients each will be enrolled in the two groups â€“ steroid and ketorolac. Patients will be followed-up at 2 weeks, 6 weeks, 3 months and 6 months to assess pain relief using VAS, functional outcome using WOMAC score, KOOS score and SF-36 score, as well as patient satisfaction on a 5-point Likert scale.*

*Expected Outcomes*: We hypothesize that ketorolac will provide better pain relief, functional outcome and patient satisfaction in knee osteoarthritis patients, at the given time-points. If it is proven, it can also be readily used as a cost-effective management option for symptomatic knee osteoarthritis patients.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 90

Inclusion Criteria

Patients with symptomatic knee osteoarthritis with K-L grade 2 or 3 on X-ray.
Patients willing to participate in the study and ready for 6 months follow-up.

Exclusion Criteria

Prior injections into the same knee within the last 1 year 2.
Failure of past treatment with corticosteroid injections 3.
Medical treatment including oral medication, physical therapy, or other analgesia use within the last one month prior to injection 4.
Pregnant/Lactating women 5.
Age <18 years 6.
Serious systemic disease 7.
Gout arthropathy 8.
Inflammatory joint disease including rheumatoid or psoriatic arthritis 9.
Known hypersensitivity to the contents of the drugs 10.
Patients with a significant effusion that requires aspiration 11.
Patients with previous history of any surgery to the same knee 12.
Secondary osteoarthritis.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
VAS score	2 weeks, 6 weeks, 3 months and 6 months

Secondary Outcome Measures

Name	Time	Method
1. Knee Function assessed using WOMAC, KSS and SF-36 scores	2. Patient satisfaction using 5-point Likert scale

Trial Locations

Locations (1): All India Institute of Medical Sciences, Nagpur
🇮🇳
Nagpur, MAHARASHTRA, India
All India Institute of Medical Sciences, Nagpur
🇮🇳Nagpur, MAHARASHTRA, India
Dr Vivek Tiwari
Principal investigator
9868633097
drvivektiwari@aiimsnagpur.edu.in